K250426
- 510(k) number
- K250426
- Device name
- Amulet Steerable Delivery Sheath
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-04-25
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K250426.pdf
Official FDA record: K250426
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.